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INSTITUTIONAL REVIEW BOARDSAMPLE CONSENT, ASSENT & PERMISSION FORMSThe following templates and samples are provided for investigators who are designingconsent, assent, or permission forms for research with human participants.Theses forms are not intended as boilerplate text. Revise bracketed and example-specific text inthe forms as appropriate to your project, keeping in mind best practices for informed consent.All forms must include the required elements described in the AU Investigator’sHandbook for the Protection of Human Participants in Research.Sample FormsPageConsent Form Template #1 . 2Consent Form Template #2 . 3Anonymous Non-sensitive Survey of Adults Sample . 6Internet Survey Template . 7Parental Permission #1 . 8Parental Permission #2 . 9“Passive” Parental Permission . 11Assent Form Sample . 12Assent Form Template . 13Greater than Minimal Psychological Risk Consent . 18Greater than Minimal Social Risk Consent . 22This material was based, in part, on information from the following sources: The IRB Guidebook, Prepared by The President's Commission for the Study of EthicalProblems in Medicine and Biomedical and Behavioral Research (2014). Levine, Robert J. Ethics and Regulation of Clinical Research, Urban & Schwarzenberg,Baltimore-Munich (1981). Sample Volunteer Consent Forms. Prepared by the Indian Health Service (William L.Freeman, MD, MPH, Chair, National IHS IRB, 2000).1
CONSENT FORM TEMPLATE #1Project Title:Project Investigator:Dissertation Chair:1. I understand that this study is of a research nature. It may offer no direct benefit to me.2. Participation in this study is voluntary. I may refuse to enter it or may withdraw at anytime without creating any harmful consequences to myself. I understand also that theinvestigator may drop me at any time from the study.3. The purpose of this study is: (to befilled in by investigator).4. As a participant in the study, I will be asked to take part in the following procedures:[to be filled in by investigator]Participants in the study will take of my time and will take place in.5. The risks, discomforts and inconveniences of the above procedures might be:(to be filled in by investigator)6. The possible benefits of the procedure might be:a.Direct benefit to me:b.Benefits to others:7. Information about the study was discussed with me by . If Ihave further questions, I can call him/her at .8. Though the purpose of this study is primarily to fulfill my requirement to complete aformal research project as a dissertation at Antioch University, I also intend to include thedata and results of the study in future scholarly publications and presentations. Ourconfidentiality agreement, as articulated above, will be effective in all cases of datasharing"If you have any questions about the study, you may contact [Dr. P. Investigator], at telephone #(XXX-XXX-XXXX) or via email at [insert email address here]. (Note: we do not recommendthat investigators provide their home phone number here. A campus office phone number ismore appropriate.)If you have any questions about your rights as a research participant, you may contact [insertname and office phone number of local IRB Chair] or [Insert name of local Provost, title, andoffice phone number].Date:Signed:2
CONSENT FORM TEMPLATE #2This informed consent form is for [BRIEF DESCRIPTION OF WHY THE PARTICIPANTS ARE]who we are inviting to participate in a research project titled “[TITLE OF RESEARCH]”.Name of Principle Investigator:Name of Organization: Antioch University, PhD in Leadership and Change ProgramName of Project: [NAME]You will be given a copy of the full Informed Consent FormIntroductionI am [NAME], a student in [NAME OF DEGREE PROGRAM]. As part of this degree, I amcompleting a project to [SHORT DESCRIPTION OF PURPOSE OF THE PROJECT]. I am going togive you information about the study and invite you to be part of this research. You may talk toanyone you feel comfortable talking with about the research, and take time to reflect on whether youwant to participate or not. You may ask questions at any time.Purpose of the researchThe purpose of this project is to [SHORT DESCRIPTION OF PURPOSE OF THE PROJECT]. Thisinformation will may us to better understand [SHORT IDENTIFICATION OF POTENTIALVALUE – AVOIDING OVERSTATEMENT THAT COULD BE SEEN AS COERCIVE].Type of Research InterventionThis research will involve your participation in a [NAME ALL TYPES OF PARTICIPATION],where your [SHORT DESCRIPTION OF PURPOSE OF THE INTERVIEW]. Each of theseinterviews will be tape recorded solely for research purposes, but all of the participants’ contributionswill be de-identified prior to publication or the sharing of the research results. These recordings, andany other information that may connect you to the study, will be kept in a locked, secure location.Participant SelectionYou are being invited to take part in this research because [NAME INCLUSION CRITERIA]. Youshould not consider participation in this research if [NAME EXCLUSION CRITERIA].Voluntary ParticipationYour participation in this study is completely voluntary. You may choose not to participate. You willnot be penalized for your decision not to participate or for anything of your contributions during thestudy. IF THIS IS WORKPLACE RESEARCH INCLUDE THIS NEXT SENTENCE: Yourposition in the [NAME WORKPLACE OR SCHOOL DISTRICT] will not be affected by thisdecision or your participation. You may withdraw from this study at any time. If an interview hasalready taken place, the information you provided will not be used in the research study.RisksNo study is completely risk free. However, I do not anticipate that you will be harmed or distressedduring this study. You may stop being in the study at any time if you become uncomfortable If you3
experience any discomfort as a result of your participation, employee assistance counselors will beavailable to you as a resource.BenefitsThere will be no direct benefit to you, but your participation may help others in the future.ReimbursementsYou will not be provided any monetary incentive to take part in this research project.OR [USE ONE OR THE OTHER STATEMENT AND DELETE THE OTHER]You will be provided [IDENTIFY COMPENSATION]ConfidentialityAll information will be de-identified, so that it cannot be connected back to you. Your real name willbe replaced with a pseudonym in the write-up of this project, and only the primary researcher willhave access to the list connecting your name to the pseudonym. This list, along with tape recordingsof the discussion sessions, will be kept in a secure, locked location.Limits of Privacy ConfidentialityGenerally speaking, I can assure you that I will keep everything you tell me or do for the studyprivate. Yet there are times where I cannot keep things private (confidential). The researcher cannotkeep things private (confidential) when: The researcher finds out that a child or vulnerable adult has been abused The researcher finds out that that a person plans to hurt him or herself, such as commitsuicide, The researcher finds out that a person plans to hurt someone else,There are laws that require many professionals to take action if they think a person is at risk for selfharm or are self-harming, harming another or if a child or adult is being abused. In addition, there areguidelines that researchers must follow to make sure all people are treated with respect and kept safe.In most states, there is a government agency that must be told if someone is being abused or plans toself-harm or harm another person. Please ask any questions you may have about this issue beforeagreeing to be in the study. It is important that you do not feel betrayed if it turns out that theresearcher cannot keep some things private.Future PublicationThe primary researcher, [YOUR NAME] reserves the right to include any results of this study infuture scholarly presentations and/or publications. All information will be de-identified prior topublication.Right to Refuse or WithdrawYou do not have to take part in this research if you do not wish to do so, and you may withdraw fromthe study at any time without your job being affected.Who to ContactIf you have any questions, you may ask them now or later. If you have questions later, you maycontact [YOUR NAME AND ANTIOCH EMAIL ADDRESS]4
If you have any questions about your rights as a research participant, you may contact [insert nameand office phone number of local IRB Chair] or [Insert name of local Provost, title, and office phonenumber].This proposal has been reviewed and approved by the Antioch International Review Board (IRB),which is a committee whose task it is to make sure that research participants are protected. If youwish to find out more about the IRB, contact Dr. Lisa Kreeger.DO YOU WISH TO BE N THIS STUDY?I have read the foregoing information, or it has been read to me. I have had the opportunity to askquestions about it and any questions I have been asked have been answered to my satisfaction. Iconsent voluntarily to be a participant in this study.Print Name of ParticipantSignature of ParticipantDateDay/month/yearDO YOU WISH TO BE AUDIOTAPED IN THIS STUDY? [IF AUDIOTAPING KEEP THIS IN.DELETE IF NOT]I voluntarily agree to let the researcher audiotape me for this study. I agree to allow the use of myrecordings as described in this form.Print Name of ParticipantSignature of ParticipantDateDay/month/yearTo be filled out by the researcher or the person taking consent:I confirm that the participant was given an opportunity to ask questions about the study, and allthe questions asked by the participant have been answered correctly and to the best of my ability. Iconfirm that the individual has not been coerced into giving consent, and the consent has been givenfreely and voluntarily.A copy of this Informed Consent Form has been provided to the participant.Print Name of Researcher/person taking the consentSignature of Researcher /person taking the consentDateDay/month/year5
ANONYMOUS NON-SENSITIVE SURVEY OF ADULTSBackground: This form might be used for an anonymous survey of adults in which no sensitiveinformation is sought. Thus, the research would be no more than minimal risk. Even though asigned consent form is not required in this type of research, the subjects must still be given thesame information that they would receive in a consent form. This information should bepresented in an instruction sheet attached to survey.Health Care Research StudyResearchers at Antioch University are asking you to fill out a survey about what servicesNoName Clinic patients need.The Researchers want to know what Clinic patients think about the health care services theyare receiving and what other services they might need. We will use the results of the surveyto plan for better health care services for everyone. We are asking all adult patients seen bythe NoName Clinic, and parents of children, to fill out the form. There are no risks to you intaking part, because we are not asking for any names and no one can know who filled out aform. It takes about 10 minutes to finish.Taking part is voluntary.If you choose not to fill out the survey, there will be no penalty and it will not affect anyservices or other benefits you might receive from NoName Clinic. If you do fill out thesurvey, you may leave any question blank, but we ask you to answer as many questionsas you can.If you have any questions about the study, you may contact [Dr. P. Investigator], at telephone #(XXX-XXX-XXXX) or via email at [insert email address here]. (Note: we do not recommendthat investigators provide their home phone number here. A campus office phone number ismore appropriate.)If you have any questions about your rights as a research participant, you may contact Dr. [insertname and of local IRB Chair], Chair of the Antioch University [insert local campus name] IRB,[insert telephone number of IRB Chair] or [Insert name of local campus chief academic officer,title, and telephone number].ACKNOWLEDGMENTS6
INTERNET SURVEYDear [describe participant],This is a survey about [short description of what the research is about]. This survey will give youan opportunity to [short description of benefits – if any – should not be overstated].Your responses will [short description of purpose of research].There are minimal, if any, risks from participating. Your identity will be anonymous andconfidential. You will not be asked for your name and all demographic data being collected willbe reported as aggregated information. No personally identifiable information will be associatedwith your responses to any reports of these data. The survey will take approximately [time inminutes]to complete.This survey is part of my dissertation research at Antioch University in the PhD in Leadershipand Change Program. he study results may be included in future presentations and publications.Your participation is voluntary and you may elect to discontinue your participation at any time.If you have any questions about the survey or the research study, please contact me at:[your contact information]This project has been approved by the Institutional Review Board at Antioch University. If youhave any questions about your rights as a research participant, please contact [insert name andoffice phone number of local IRB Chair] or [Insert name of local Provost, title, and office phonenumber].I have read and understood the above information. By clicking "Next" below, I am indicatingthat I have read and understood this consent form and agree to participate in this research study.Please print a copy of this page for your records.Thank you for your participation!7
PARENTAL PERMISSION #1DateDearThis year I am enrolled in a Master’s of Education program at Antioch University New England.Part of my required coursework includes a Master’s Project. My project is focused on This work will contribute to my work and the experience of the students by I will be reading books and articles, attending workshops and seeking other resources to informmyself about (the topic). I will collect information from activities in the classroom andconversations with students. The project will include (surveys, interviews, observations, etc.).These activities will not interfere with classroom time, or involve any risk. The project will helpto inform my practice, my knowledge about learning processes, and the students.The results of this project may be used for classroom discussion in my graduate work,professional presentations, articles, and other purposes related to teacher education. Primarily itwill be used for my own professional development.In all written materials and presentations the names of students will not be used. Pseudonymswill be substituted for all names. Every effort will be made to protect the anonymity ofparticipants. Photos (or videos) taken in the course of this project will be used to illustrategeneral aspects of the project not to identify individual students and will be destroyed or erasedat the end of the project.I plan to discuss this project with the students. I would be happy to discuss any aspect of theproject with you. Your child’s participation is completely voluntary. You do not have to allowyour child to be part of this project. If at any time, or for any reason, you wish not to have yourchild involved in the project please let me know.If you have any questions about the study, you may contact [Dr. P. Investigator], at telephone #(XXX-XXX-XXXX) or via email at [insert email address here]. (Note: we do not recommendthat investigators provide their home phone number here. A campus office phone number ismore appropriate.)If you have any questions about your rights as a research participant, you may contact [insertname and office phone number of local IRB Chair] or [Insert name of local Provost, title, andoffice phone number].Sincerely,Print Child’s NamePrint Parent or Guardian’s NameParent or Guardian Signature Date8
PARENTAL PERMISSION #2Student's Name Grade:Dear Parent:Researchers at Antioch University New England are asking permission for your child to be in aresearch study on reading.The study compares children reading below grade level with those reading at or abovegrade level on various measures of learning and memory.We selected your child based on the testing you agreed to when your child started school.With your permission, s/he will work with a person from the University on six occasionsfor approximately 20-30 minutes each time. During each session, s/he will be working ona variety of tasks designed to measure learning, memory and other things related toreading. The tasks are not difficult and in most instances the children find them quiteenjoyable.We will see each child on a one-to-one basis and arrange scheduling with his/her teacherto make sure that s/he does not miss important classroom activities. This study has theapproval and support of your child's school.Your child's responses will remain confidential.No reports about the study will contain your child's name. We will not release anyinformation about your child without your permission.Taking part is voluntary.If you choose not to have your child take part, neither you nor your child will bepenalized.We will also ask your child to participate and only children who want to will take part inthe study. Your child may choose to stop at any time.If you have any questions about the study, you may contact [Dr. P. Investigator], at telephone #(XXX-XXX-XXXX) or via email at [insert email address here]. (Note: we do not recommendthat investigators provide their home phone number here. A campus office phone number ismore appropriate.)If you have any questions about your rights as a research participant, you may contact [insertname and office phone number of local IRB Chair] or [Insert name of local Provost, title, andoffice phone number].Attached is a form for you to sign. Please indicate whether or not you agree to have your child bein the study and have him/her return the form to school tomorrow. We would greatly appreciateyour cooperation in this research.9
READING STUDY PERMISSION FORMI have read and understood the information provided to me about the research study on readingbeing conducted in my child's classroom by researchers from Academia University.I giveI do not give permission to have my child (Child's Name) included in the study.(Parent's Signature)Date10
PASSIVE" PARENTAL PERMISSIONDear Parent:Researchers at Antioch University are asking permission for your child to be in a research studyon teaching math.During the next week, researchers from Antioch University will be conducting a researchstudy in your child's classroom. The study compares different methods of teachingmathematical concepts. We will not interact directly with your child. His/her teacher willsimply be presenting the material in two different ways to separate classes.Both teaching methods are acceptable methods for teaching these concepts and your childwill receive adequate instruction in both classes. The only measure of performance willbe a standard math test. This test will not be a part of your child's record and will notaffect his/her grade in any way.Your child's responses will remain confidential.No reports about the study will contain your child's name. We will not release anyinformation about your child without your permission.Taking part is voluntary.All students in the class will take the test. If you do not wish your child to be in thisstudy, which will mean that we won't include his/her test results in the data, please fill outthe form at the bottom of this letter and return it to me. In addition, please instruct yourchild to hand in a blank test sheet so that we will not include him/her in the research. Wewill also ask the children to participate and tell them to hand in a blank test sheet if theydo not want to be included. Your child may choose to stop at any time.If you have any questions about the study, you may contact [Dr. P. Investigator], at telephone #(XXX-XXX-XXXX) or via email at [insert email address here]. (Note: we do not recommendthat investigators provide their home phone number here. A campus office phone number ismore appropriate.)If you have any questions about your rights as a research participant, you may contact [insertname and office phone number of local IRB Chair] or [Insert name of local Provost, title, andoffice phone number].I do not wish my child to be in the research study on teachingmath being conducted in his/her classroom.(Parent's Signature)11
ASSENT FORM SAMPLEStudent's NameSchoolRESEARCH STUDY ON READINGDo you remember the permission slip you took home for your parents to sign a few days ago?The people I work with and I are interested in learning about reading in children. We are askingyou and a lot of other kids to work with us to find out about it.If you agree to do this, I will ask you to take a reading test and solve some puzzles. Most kidsthink this is fun to do.This is not a test like you usually have in school. You won't be graded on anything you do andthe results will not affect your school grade. All you have to do is try as hard as you can to do thethings I ask, and you will do fine.Your teachers and parents and the other children will not know how you do. It will be justbetween you and me and the people I work with.Of course, you don't have to do this if you don't want to, even if your parents gave theirpermission. If you do not want to do this or your parents asked you not to do this, just tell me andyou can go back to your classroom. It is OK with me if you don't want to be in the study and noone else, not even your teacher, will know.Do you have any questions?[The Experimenter should answer any question the child might have]Again, this will not affect your grades even if you choose not to be in the study. If you agree todo this, I would like you to sign this paper.[If necessary, the Experimenter reads assent statement to the child.]The study on reading has been explained to me and any questions I had have been answered. Iwould like to take part in the study.Student's SignatureDate12
ASSENT FORM TEMPLATEStudy Title:Researcher:Email Address and Telephone Number:Research Supervisor:Email Address:You are invited to be part of a research study. The researcher is a doctoral learner at [INSERTSCHOOL HERE]. The information in this form is provided to help you decide if you want toparticipate. The form describes what you will have to do during the study and the risks andbenefits of the study.If you have any questions about or do not understand something in this form, you should ask theresearcher. Do not sign this form unless the researcher has answered your questions and youdecide that you want to be part of this study.WHAT IS THIS STUDY ABOUT?The researcher wants to learn about [RESEARCH TOPIC SUMMARY HERE].WHY AM I BEING ASKED TO BE IN THE STUDY?You are invited to be in the study because you are: [INSERT INCLUSION CRITERIA] [INSERT INCLUSION CRITERIA]All participants will be between [INSERT AGE RANGE HERE].If you do not meet the description above, you are not able to be in the study.HOW MANY PEOPLE WILL BE IN THIS STUDY?About [INSERT NUMBER OF PARTICIPANTS] participants will be in this study.WHO IS PAYING FOR THIS STUDY?The researcher is not receiving funds to conduct this study.ORThe researcher is employed at [INSERT NAME OF RESEARCH SITE], but is not receivingfunds to conduct this study. The researcher will not be paid for conducting the study. [Use thisspace to disclose other potential conflicts of interest, such as financial considerations]WILL IT COST ANYTHING TO BE IN THIS STUDY?Your parent/guardian does not have to pay to be in the study.WHAT WILL HAPPEN DURING THIS STUDY?If you decide to be in this study and if you sign this form, you will do the following things:[SELECT ONE OR MORE OF THE FOLLOWING ACTIVITIES. OMIT ACTIVITIESWHICH WILL NOT BE PART OF THE STUDY] give personal information about yourself, such as your age, gender, occupation, andeducation level.13
answer questions during an interview about [INSERT STUDY INFORMATION HERE].answer questions during a focus group about [INSERT STUDY INFORMATIONHERE].complete a survey about [INSERT STUDY INFORMATION HERE].allow a researcher to observe you while you [DESCRIBE ACTIVITY HERE].allow a researcher to look at your records [DESCRIBE RECORDS].While you are in the study, you will be expected to: Follow the instructions you are given. Tell the researcher if you want to stop being in the study at any time.WILL I BE RECORDED?The researcher will audiotape your [describe what will be recorded – i.e. interview, focus group,XXX activity]. The researcher will use the audiotape in order to [INSERT DESCRIPTIONHERE]The researcher will only use the recordings of you for the purposes you read about in this form.They will not use the recordings for any other reasons without your permission unless you signanother consent form. The recordings will be kept for seven years and they will be keptconfidential. The recordings will be destroyed after seven years.WILL BEING IN THIS STUDY HELP ME?Being in this study will not help you. Information from this study might help researchers helpothers in the future.ARE THERE RISKS TO ME IF I AM IN THIS STUDY?No study is completely risk-free. However, we don’t anticipate that you will be harmed ordistressed during this study. You may stop being in the study at any time if you becomeuncomfortable.OR:As part of the study you may [describe risks, including the likelihood and magnitude of risk.Disclose all risks (social, financial, psychological, or possible physical risks) and they must betold under what conditions their participation in the study can be terminated by the researcher.]WILL I GET PAID?If you participate, you will be paid [ENTER AMOUNT HERE]OR:If you participate, you will receive a [ENTER AMOUNT HERE] gift card to [ENTER NAMEHERE]OR:You will not receive anything for being in the study.DO I HAVE TO BE IN THIS STUDY?Your participation in this study is voluntary. You can decide not to be in the study and you canchange your mind about being in the study at any time. There will be no penalty to you. If youwant to stop being in the study, tell the researcher.Your parent(s)/guardian(s) have also said that you may participate in this study.14
The researcher can remove you from the study at any time. This could happen if: The researcher believes it is best for you to stop being in the study. You do not follow directions about the study. You no longer meet the inclusion criteria to participateWHO WILL USE AND SHARE INFORMATION ABOUT MY BEING IN THIS STUDY?Any information you provide in this study that could identify you such as your name, age, orother personal information will be kept confidential. [EXPLAIN HERE HOW INFORMATIONWILL BE KEPT CONFIDENTIAL]. In any written reports or publications, no one will be ableto identify you.The researcher will keep the information you provide in a [PASSWORD PROTECTEDCOMPUTER AND/OR A LOCKED FILE CABINET] in [LOCATION] and only the researcher,research supervisor, and [LIST OTHER INDIVIDUALS] will be able to review this information.[IF TAPE RECORDINGS ARE MADE, EXPLAIN WHO WILL HAVE ACCESS TO THEM]Even if you leave the study early, the researcher may still be able to use your data. [DESCRIBEUNDER WHICH CIRCUMSTANCES THEIR DATA COULD STILL BE USED]Limits of Privacy ConfidentialityGenerally speaking, I can assure you that I will keep everything you tell me or do for the studyprivate. Yet there are times where I cannot keep things private (confidential). The researchercannot keep things private (confidential) when: The researcher finds out that a child or vulnerable adult has been abused The researcher finds out that that a person plans to hurt him or herself, such as commitsuicide, The researcher finds out that a person plans to hurt someone else,There are laws that require many professionals to take action if they think a person is at risk forself-harm or are self-harming, harming another or if a child or adult is being abused. In addition,there are guidelines that researchers must follow to make sure all people are treated with respectand kept safe. In most states, there is a government agency that must be told if someone is beingabused or plans to self-harm or harm another person. Please ask any questions you may haveabout this issue before agreeing to be in the study. It is important that you do not feel betrayed ifit turns out that the researcher cannot keep some things private.Future PublicationThe primary researcher, [YOUR NAME] reserves the right to include any results of this study infuture scholarly presentations and/or publications. All information will be de-identified prior topublication.Right to Refuse or WithdrawYou do not have to take part in this research if you do not wish to do so, and you may withdrawfrom the study at any time without your job being affected.15
Who to ContactIf you have any questions, you may ask them now or later. If you have questions later, you maycontact [YOUR NAME AND ANTIOCH EMAIL ADDRESS]If you have any quest
Name of Organization: Antioch University, PhD in Leadership and Change Program Name of Project: [NAME] You will be given a copy of the full Informed Consent Form Introduction I am [NAME], a student in [NAME OF DEGREE PROGRAM]. As part of this degree, I am completing a project to [SHORT DESCRIPTION OF PURPOSE OF THE PROJECT].
